We want to inform you that Advanced Medical Optics (AMO) is immediately and voluntarily recalling its Complete® MoisturePlus™ contact lens solution. The U.S. Centers for Disease Control and Prevention (CDC) made data available to AMO on May 25, 2007 showing that it had interviewed 46 patients who had developed Acanthamoeba keratitis (AK) infections reported since January 2005. A total of 39 of these patients were soft contact lens wearers, 21 of whom reported using Complete® MoisturePlus™ product. The CDC estimates a risk of at least seven times greater for those who used Complete® MoisturePlus™ solution versus those who did not. This recall is being conducted on a voluntary basis, in cooperation with the U.S. Food and Drug Administration (FDA).

While AMO continues to work with the CDC and the U.S. Food and Drug Administration (FDA) to further assess the data, it is acting with an abundance of caution and has decided to remove AMO Complete® MoisturePlus™ from the market. There is no evidence to suggest the May 25th voluntary recall is related to a product contamination issue and this does not impact any of AMO’s other contact lens products, including our family of hydrogen peroxide disinfecting solutions. As patient safety is paramount to AMO, the company is taking decisive action to stop shipments, recall product from the marketplace, and encourage consumers to discontinue the use of AMO Complete® MoisturePlus™ solution.

At this time, we ask for your help to keep patients and consumers safe.

- Please return your current supply of AMO Complete® MoisturePlus™ as instructed below.
- Advise patients to discontinue use of AMO Complete® MoisturePlus™. Please direct your patients to call 1-888-899-9183 for additional information regarding this recall and how to return the product.
- Should you receive inquiries about AMO Complete® MoisturePlus™ from concerned patients, please refer them to the consumer hotline at 1-888-899-9183, or Website at www.amo-inc.com.

In the next few days, you will be receiving by mail, a package with general instructions for returning product. Upon receipt, please follow these instructions:

1. Complete the enclosed Business Reply Card and return it via U.S. mail within 5 days. It is important to return the card even if you do not have any of the affected product.

2. Complete the enclosed Packing Slip and affix the provided pre-paid UPS shipping labels to return your product to: Stericycle, 2670 Executive Drive, Suite A, Indianapolis, IN 46241; Stericycle is conducting this recall on behalf of Advanced Medical Optics.

Please report any adverse reactions experienced with the use of this product, and/or quality problems to AMO by calling 1-800-347-5005 and to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

While AMO believes the likelihood of users experiencing an adverse reaction is low, we have taken a cautious approach and are conducting the recall in the best interests of our customers. This action is being conducted on a voluntary basis in cooperation with the FDA.

We apologize for the inconvenience this has caused. AMO has built its reputation on consumer trust and the assurance that we provide products that meet the highest standards. Our first priority is protecting the ocular health of those who use our products and as such, we appreciate your assistance with this matter.

Please do not hesitate to contact me if I can answer any questions or be of service. You can also find additional information by calling 1-888-899-9183 Monday through Friday between 8 a.m. and 5 p.m. Eastern Time, or by visiting our Web site at www.amo-inc.com.

Regards,

David W. Hansen, OD, FAAO (DiplCL)
Advanced Medical Optics, Inc. (AMO)

Comments(0)

LASIK involves creating a corneal flap and treating the underlying tissue. PRK brushes aside the outer Epithelial layer of the cornea and treating the underlying tissue with the same laser as with LASIK. Which procedure is best for a patient’s needs?

The question often asked is “should I have LASIK or PRK and why?” The answer is not as easy and choosing the procedure involves both physiological testing results which determines which surgery will get the best final results, patient time line and expectations. LASIK patients can expect to get up after surgery and see better that same day, although it may take several to achieve the final results. The issue to consider is what environment the patient lives in. For example, if the individual is in a high risk profession like a police officer, military personel or any other occupation that may expose that person to eye trauma, there is a real chance that the flap may dislodge and move. Moving a flap can be devastating to the eye and require immediate surgery to correct the problem. In addition, if exposed to certain chemicals like pepper spray the flap may experience Diffuse Lamellar Keratitis (DLK) which makes the cornea hazy. Also, debris may work itself under the flap if the environment is filled with pollution. This would mean that someone may have to delay entrance into the Police, Fire or military academies for 6-9 months following surgery to give the cornea adequate time to fully heal.

PRK does not have a corneal flap and therefore is not at risk for the DLK or flap movement if exposed to trauma. In addition, nothing can get under a flap. Therefore the risk of post surgical complication is less. Healing time and time required to have good vision is much longer then with LASIK. It may take several weeks to achieve that point. So if time is an issue LASIK will get there faster, but for reduced likelihood of flap complications PRK is much safer. The only issue with PRK is that the corneal Keratocytes are very sensitive to UV light and thus the patient must wear sunglasses every day for at least a year until the cornea is fully healed.

In short, for professions that may expose an individual to eye trauma or air pollutants LASIK may not be the best procedure to have. PRK is much better, but does require more time to see better post surgically.

Comments(0)

The retina is comprised of 10 seperate layers that attach to the underlying sclera. This retinal tissue is very delicate and at any point if subjected to the right conditions will seperate from the sclera. However, it is not necessary for the entire retinal to come off for there to be a serious problem.

The eye is mainly filled with jelly called Vitreous which is attached to the retina in 3 areas. Any traction on the retina from the vitreous may be enough pressure to pull a piece off.

There are 3 seperate but related retinal problems with regard to traction. The first is a retinal hole. This occurs when a piece of the retina actually pulls off attached to the vitreous and leaves a circular opening in the outer layers of the retina. Frequently, the patient will see a floater or small specs floating in their eyes. This may be accompanied by flashes of light. Second, is a retinal tear. This occurs when the tissue tears and may be several shapes. Depending on location and size, this may be mild or very severe. Both of these conditions require laser treatment to seal them down. If left untreated, fluid may leak under the retina and cause the most serious of conditions a retinal detachment. This is when the retina pulls off in sheets. It frequently is accompanied by bleeding into the eye. Symptoms for a detachment vary, but usually are flashes of light, floaters and distorted vision where the detachment is. In addition, if it is in the superior retina, a veil or shade may appear to be in front of the vision. On occasion, the individual may also see red or pink in their eye. This is blood.

When any of these symptoms occur, it is important to see an eye doctor as soon as possible. A complete dilated retinal exam must be done with a binocular indirect ophthalmoscope and a 90 diopter lens. This is the only and best way to evaluate the retina. In cases where blood obscures a clear view, an A scan can be performed to check for retinal detachments.

In short, flashes of light, floaters and visual distortion may be signs of retinal holes, tears and detachments. If you experience any of these symptoms, see your eye doctor at yourt earliest convenience.

Comments(0)

LASIK is a refractive surgical procedure that reduces or eliminates the need for eye glasses and contact lenses. It involves creating a flap in the cornea, lifting it up and using a laser to reshape the underlying tissue. The basic concept is to shape the cornea to focus light on the retina with out the need of any refractive aid. The flap may be created by a blade or a laser called Intralase. The Intralase method is more precise and heales with minimal scaring, but because the flap is so thin increases the possibility of corneal striae. These are folds in the tissue that can reduce vision. In mild cases of striae no additional therapy is required, but if more pronounced does require going back into surgery to lift and smoothen out the flap.

The most serious complication of LASIK is Ecatsia. This occurs when the cornea heals in an irregular fashion resulting in distorted refractive tissue. The results can be devistating. A recent patient in our office who had LASIK 4 years previously had best corrected visual acuities of 20/60 in each eyes. He was mildly nearsighted prior to surgery with a prescription of -200 in each eye. Post surgically he has an Rx of about -700 in each eye and astigmatism of -450. Even with this prescription he has distorted vision of 20/60. As a result of these strong eye glasses, he was also fit with custom made contact lenses. This maximizes his visual comfort, but the lenses are very expensive and take 2-3 weeks to manufacture.

How then can a patient avoid getting Ectasia with LASIK and how should the surgeon determine if LASIK should be performed. The answer to both questions is an instrument called an Orbscan. This computer evaluates the front and back surface of the cornea in extreme detail. NO LASIK should ever be done with out an Orbscan being done first. If the posterior surface (endothelium) of the cornea deviates more then .47 from the average cornea as determined by the computer, then LASIK should not be done. That measurement determines the likelihood of getting Ectasia post surgically. If the patient is not a LASIK candidate then PRK can be performed since Ecatasia does not occur with PRK.

The best refractive surgeons always do an Orbscan and will perform PRK as often as required. LASIK is not for everyone and should not be performed on all patients.

Comments(0)

An estimated 20% of the world’s population suffers from allergic disease and may present as red itchy eyes, rhinitis (runny nose), asthma, and allergic conjunctivitis.

Ocular allergies are specific immunologic changes that result in inflammation on the conjunctival surface. This is a response to an increased level of Mast cells in the surface tissue and will result in a mild allergic reaction. When immunoglobulin E is introduced and interacts with a mixture of mast cells, lymphocytes and eosinophils, the allergic response is more severe and corneal involvement is much more likely.

There are several types of allergic reactions that affect the eyes. Seasonal allergic conjunctivitis is one of the most common types and is a typical reaction to Ragweed pollen and other environmental allergens. Perennial allergic conjunctivitis is a variant of the seasonal type, but reoccurs yearly in response to exposure to a certain allergen. Vernal conjunctivitis is uncommon and is a chronic type of the seasonal allergic conjunctivitis. This type more often occurs in children. Giant Papillary Conjunctivitis is most often associated with contact lens wear and is a reaction to exposure to surface debris. It results in follicles and papilla (bumps) on the inside surface of the lids. Finally, contact dermatitis is an acute response to exposure to an allergen. It results from touching an allergen and then rubbing the face or eye lids. This causes exposure and red, itchy, scaly skin is the result. There may be ocular involvement if the eye is exposed as well as the skin.

Treatment options vary depending on which allergy the patient suffers from. Surface allergies like contact dermatitis are best treated initially by cool compresses. Oral antihistamines interfere with systemic involvement, but are not the best choice for the surface disease of the eyes. Vasoconstrictors are available over the counter, but don’t work that well for moderate to severe reactions.

Mast cell stabilizers have been around for some time and are effective in reducing some of the symptoms, but still leave the patient uncomfortable. The newest treatment modality is the combination multi-action surface medicine like Patanol and Pataday. This medication is comprised of mast cell stabilizers and antihistamines. They attack the entire source of the disease process. Relief is quick and with Pataday which is a single does per 24 hours, long lasting and easy to use. The only stronger topical medication is steroids. They will resolve the symptoms and red eyes and are used in severe allergic reactions. The only problem is that they can NOT be used for prolonged treatment due to the severe side affects. When a bad allergy is encountered, steroids can be employed to start the treatment and then change to medications like Patanol/Pataday for long term therapy.

In short, ocular allergies are very common and cause substantial discomfort in affected individuals. New treatments and medications eliminate these symptoms and permit the individual to live a normal life during previously difficult times.

Comments(0)

Kerataconus is a genetic recessive degenerative corneal condition that may present in various degrees of severity. Most often symptoms will begin in the mid twenties and continue to change for several decades. It is a condition that is presented in .06% of the population and some people never even know that they have the condition.

The mildest form of the condition usually just presents with a steep cornea and a normal prescription that includes astigmatism. The best corrected vision is about 20/20. As the severity of the disease increases the vision gets worse and is more difficult to correct. The prescription includes more astigmatism and the cornea becomes steeper and irregular. Frequently, Kerataconic patients rub their eyes a lot and complain of itching of the eyes and lids. Theories have been discussed as to weather the rubbing caused the Kerataconus and the condition causes the itching. The best way to diagnose the disease is with the use of a Corneal Topographer.

As the condition worsens corneal distortion increases. In order to improve the visual acuity, often hard contact lenses are required. Following this development the apex of the corneal “cone” tends to scar as the hard lens/corneal interface increases. On occasion, a piggy back method of contact lens wear is needed to maintain comfort of the lens. This includes wearing a soft contact lens under the hard lens as a barrier to protect the ever increasing steepening cornea. Once this presentation of the disorder occurs central corneal thinning follows, and small micro-cystic edema begins. This appears as little bubbles in the cornea. At this stage pain may be felt.

When the cornea becomes too thin, the best vision is unacceptable to the patient, and pain ensues, a corneal transplant must be considered. This procedure involves getting a donor cornea and actually removing the damaged Kerataconic one. Healing may take as long as a year and there is always a chance of corneal graft rejection.

In short Kerataconus decreases vision over a period of years, distortion, itching and pain may also occur. Most patients can be corrected by the use of hard contact lenses, but in the worse case scenario, a corneal transplant corrects the condition.

Comments(3)

Dry eyes may result when the eyes do not produce either enough or a poor quality tears. The tears are manufactured in the Lacrimal gland and other glands in the eye and are comprised of 5 comp0nents. Among the parts of the tears are enzymes, water and mucous. If any part is not represented in sufficient quantity, then the tear film will not coat the cornea properly. This will result in dry , sandy, burning red eyes.

A lack of quantity of the tears will result in the same symptoms. Decreased tear quality or quantity may result from infection, trauma, blocked tear glands called Meibomianitis, disease and even age. If the glands in the lids are blocked then lid cleaning, warm compresses and even oral medication may be required to alleviate the condition.

Traditionally, artificial tears like Systane, Refresh or Genteal were recommended, but a new treatment has shown to be very effective in reducing the symptoms and condition. If left untreated in certain cases the cornea my become scared, and thus reduce the vision. The new treatment modality includes the use of topical steroid eye drops like Lotemax 3 times per day for 2-3 weeks, artificial tears 4 times per day and the use of Omega III pills. Since the new theory is that dry eyes are caused by an allergy involving the tear producing glands and then an inflammatory condition of this same tisuue, this treatment modality addresses these concerns individually and increases tear production. It does require at least 2-3 months to begin to notice improvement in symptoms. If this treatment does not resolve the condition then Restasis eye drops is prescribed. This is Cyclosprin which is an old medication and is an anti-autoimmune medication. It has been shown to increase tear production. It is quite expensive and does take at least 2-3 months to begin working. The patient must continue its use for 6-12 months for remediation of the symptoms.

If this treatment still does not completely eliminate the dry eyes, then Punctal plugs must be inserted. These are either collagen or synthetic plugs that are placed in the drainage area in the cornea of the lids. This prevents the tears from leaving the eye and thus improves comfort. The final treatment as a last resort is the use of wet cell eye glasses. These are glasses that look like swimming goggles and retain moisture in the eye area by physically sealing in the tear film.

In short, dry eyes are a common condition, but must be treated to prevent long term damage to the eye and keep an individual comfortable. Refractive surgery also causes dry eyes, but usually resolves with in 3 months. If your eye are dry then use artificial tears and see your eye doctor if the symptoms persists.

Comments(0)

PRK is a surgical procedure that reduces or eliminates the need for eye glasses. It involves brushing off the Epithelium or outer layer of the cornea and then treating the underlying tissue with a laser. This reshapes the cornea to correct any nearsightedness, farsightedness and astigmatism. Complete healing may take days to weeks to months depending on the individual tissue physiology.

Antibiotic and steroid eye drops are used to help in the healing process, and are modified as the corneal tissue regenerates. Under normal circumstances the epithelium regenerates in less then a week, but the protein in the cornea may take much longer to fully heal.

A variable that has shown to be a significant issue is the introduction of the sun’s high energy UV light. During the first year after surgery the Keratocytes in the cornea are especially sensitive to this UV light. In certain individuals exposure of these corneal cells to UV light will result in a hazy corneal appearance. This will decrease the person’s vision, create more glare and may even give the cornea a whitish appearance. To the examining eye doctor the cornea appears to have hexagonal areas in the central part of the cornea.

Treatment involves the use of steroid eye drops like FML or Pred Forte for a peroid of 1-2 months. If the haziness does not resolve during that period, then a second surgical procedure is required to brush away this hazy area. Post surigical treatment then resumes as before.

What then can the patient do to prevent this hazy cornea from occuring? The answer is quite simple. ALL post surgical patients that have had PRK MUST wear good quality sunglasses EVERY time they are outside during daylight hours. This must be done for at leats the first year post surgically. It is a good idea to wear them any way, but a must following the surgery. In most if not all cases the hazy cornea will be prevented by wearing the sunglasses.

Be compliant and prevent problems.

Comments(0)

With the warm weather coming many people are getting in shape and spending more time outdoors. Proper eye wear is critical for the best vision, safety and protection of the eyes.

The number one issue is to wear good quality sunglasses that will protect the eyes from the UV radiation generated by the sun. Clinical studies have demonstrated that the sun causes retinal burns, Macular Degeneration when there is a genetic predisposition, Cataracts, Pinguecula and Pterygia. Good quality sun wear are those that filter out all the harmful sun rays. In this case you do get what you pay for. Inexpensive sunglasses will NOT protect your eyes well enough. They will increase the size of your pupils thus letting MORE not less harmful rays in since they do not filter out enough radiation. Among the best sunglasses are Maui Jim, Ray Bans, and other well known names. Always avoid the stylish sunglasses that look great but have little protective value. If the sunglasses are to be worn during sporting activities, then the lenses should be made out of Polycarbonate. These are safety lenses and will prevent injuries from trauma. Cycling, tennis and racquetball are only a few of the sports that we see summer injuries from relating to sunglasses.

Contact lenses are also used for many sports. For active sports with quick movements, large lenses are available that stay in place better and are more stable then the regular size lenses. These lenses are NOT disposable, but are much better for sports then other lens designs. With regard to swimming and water sports, the only good lens is a daily disposable. All other lenses may become contaminated by water borne micro-organisms and cause very bad eye infections that are usually misdiagnosed at first. The daily lenses are thrown away after each use and thus prevent any secondary infections. For diving, the best alternative is still a prescription mask as is the Rx swimming goggles. We do a lot of these, this time of year. Contacts may become dislodged when clearing the mask and may adhere to the cornea on deeper dives.

We custom tint sunglass contact lenses for surfers and other out door athletes. They are strictly for out door use and some folks prefer other alternatives, but they are still quite popular this time of year.

The bottom line is to address your individual needs and get eye wear that is appropriate for those activities. Running, swimming and all other sunglasses/contact lenses are made for all individuals and it is best to be well informed about your needs and wear what you need.

Comments(0)

The cornea is the clear front part of the eye and acts as the window to the eye. It also represents about 45% of the refractive power of the eye. Unfortunately, if anything happens to the cornea, it will have a devastating affect on an individual’s vision.

When the cornea loses it’s transparency, a corneal transplant, known as a graft is often required. This may be due to trauma, burns, injury, drugs, disease and congenital issues. Diseases like Keraticonus represent a large percentage of the graft patients.

A corneal transplant requires a donor, and the damaged cornea is removed and the new one is attached in it’s place. Healing time may be as long as a year, and the vision takes months to return. A new procedure has changed all of this. It is called Descemet Stripping Automated Endothelial Keratoplasty ( DSAEK), and will revolutionize corneal grafts. It involves making a small incision in the cornea and then stripping the endothelium or inner most layer. The the donor tissue is folded, inserted, and placed up against the area where the endothelium was. Normal pressure in the eye reattaches the donor tissue. Healing time is within several months and vision improves in weeks to months. There is much less discomfort, no sutures and much less invasive.

DSAEK is only good for endothelial corneal problems such as FUCHS Dystrophy and Bullous Keratopathy due to compromised endothelium. This procedure may prove to be a huge step forward in treating corneal disease.

Comments(0)